Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee, 39403-39404 [2011-16828]
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Federal Register / Vol. 76, No. 129 / Wednesday, July 6, 2011 / Notices
families. The data also will have
significant implications for policy and
program development for child wellbeing programs nationwide.
The purpose of this request is to
obtain OMB approval for an extension
of the original three year request which
was approved on March 31, 2009. Fortythree of the original 53 grantees were
awarded for a five-year grant period,
thus necessitating an extension of the
original request in order to continue
data collection for the remainder of the
grant period. The first submission of
RPG grantee data to the RPG data
collection system ocurred in December,
2008, and every six months thereafter.
Data collection will be conducted for
the fifth year of the grant period, ending
September 30, 2012, with data
submission by January 2013. Data
collection may be extended for one year
until January 2014 should grantees
request and be granted no-cost
extensions.
To minimize grantee data collection
and reporting burden, many of the data
elements are already being collected by
counties and States in order to report
Federally-mandated data for the
Adoption and Foster Care Analysis and
Reporting System (AFCARS), the
Treatment Episode Data Set (TEDS) and
the National Outcome Measures
(NOMs); in addition, all States
voluntarily submit data for the Federal
National Child Abuse and Neglect Data
System (NCANDS). Therefore, most
child welfare data elements included in
the RPG performance measures can be
found in a State’s automated case
management system, which is often a
Federally-funded Statewide Automated
Child Welfare Information System
(SACWIS). TEDS admission and
discharge data are collected by State
substance abuse agencies according to
their own information systems for
monitoring substance abuse treatment
admissions and transmitted monthly or
quarterly to the SAMHSA contractor.
As a result of prior Federal
government reporting requirements,
States are already collecting several data
elements needed by the RPGs. The RPG
lead agency or their state or local
partners are able to download
information from these existing State
child welfare and substance abuse
treatment data systems to obtain data to
monitor their RPG program outcomes,
thereby reducing the amount of primary
data collection needed.
Respondents: RPG Grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
26
17
2
2
175.50
175.50
9,126
5,967
Estimated Total Annual Burden Hours .....................................................
sroberts on DSK5SPTVN1PROD with NOTICES
State, local, and Tribal Government ................................................................
Private Sector ..................................................................................................
........................
........................
........................
15,093
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
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18:17 Jul 05, 2011
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other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–16789 Filed 7–5–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for a Nonvoting Industry
Representative and Request for
Nominations for a Nonvoting Industry
Representative on an FDA Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00028
Fmt 4703
Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by August 5, 2011, for vacancies
listed in the notice. Concurrently,
nomination material for prospective
candidates should be sent to FDA by
August 5, 2011.
DATES:
All letters of interest and
nominations should be submitted in
writing to Gail Dapolito (see FOR
FURTHER INFORMATION CONTACT).
ADDRESSES:
Gail
Dapolito, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
FOR FURTHER INFORMATION CONTACT:
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
SUMMARY:
PO 00000
nonvoting industry representative to
serve on its Cellular, Tissue, and Gene
Therapies Advisory Committee notify
FDA in writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve its Cellular,
Tissue, and Gene Therapies Advisory
Committee. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nomination
will be accepted for current vacancies
effective with this notice.
Sfmt 4703
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06JYN1
39404
Federal Register / Vol. 76, No. 129 / Wednesday, July 6, 2011 / Notices
1448, 301–827–1289; Fax: 301–827–
0294; E-mail: gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Cellular, Tissue, and Gene Therapies
Advisory Committee
The Agency requests nominations for
a nonvoting industry representative on
the Cellular, Tissue, and Gene Therapies
Advisory Committee. The Cellular,
Tissue, and Gene Therapies Advisory
Committee advises the Commissioner of
Food and Drugs (the Commissioner) or
designee in discharging responsibilities
as they relate to the regulation of
cellular and gene therapy products.
This committee has 13 voting
members. Members are asked to provide
their expert scientific and technical
advice to FDA to help make sound
decisions on the safety, effectiveness,
appropriate use, and labeling of cellular
and gene therapy products.
sroberts on DSK5SPTVN1PROD with NOTICES
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the Cellular, Tissue, and
Gene Therapies Advisory Committee.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
the 30 days (see DATES). FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
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18:17 Jul 05, 2011
Jkt 223001
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the cellular and gene
therapy products biotech industry.
This notice is issued under the
Federal Advisory Committee Act
(5 U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: June 29, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–16828 Filed 7–5–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 8, 2011, from 8 a.m.
to 5 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
The Ballroom, 3501 University Blvd.
East, Adelphi, MD 20783–7998. The
conference center’s telephone number is
301–985–7300.
Contact Person: Kristina Toliver,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, e-mail:
CRDAC@fda.hhs.gov, or FDA Advisory
PO 00000
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Fmt 4703
Sfmt 4703
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On September 8, 2011, the
committee will discuss new drug
application (NDA) 202439, rivaroxaban
tablets, submitted by Johnson & Johnson
Pharmaceutical Research and
Development, L.L.C., on behalf of OrthoMcNeil-Janssen-Pharmaceuticals, for the
prevention of stroke and systemic
embolism (blood clots other than in the
head) in patients with nonvalvular atrial
fibrillation (abnormally rapid
contractions of the atria, the upper
chambers of the heart).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 24, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
16, 2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Notices]
[Pages 39403-39404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for a Nonvoting Industry
Representative and Request for Nominations for a Nonvoting Industry
Representative on an FDA Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on its Cellular, Tissue,
and Gene Therapies Advisory Committee notify FDA in writing. FDA is
also requesting nominations for nonvoting industry representatives to
serve its Cellular, Tissue, and Gene Therapies Advisory Committee. A
nominee may either be self-nominated or nominated by an organization to
serve as a nonvoting industry representative. Nomination will be
accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by August 5,
2011, for vacancies listed in the notice. Concurrently, nomination
material for prospective candidates should be sent to FDA by August 5,
2011.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-
[[Page 39404]]
1448, 301-827-1289; Fax: 301-827-0294; E-mail:
gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Cellular, Tissue, and Gene Therapies Advisory Committee
The Agency requests nominations for a nonvoting industry
representative on the Cellular, Tissue, and Gene Therapies Advisory
Committee. The Cellular, Tissue, and Gene Therapies Advisory Committee
advises the Commissioner of Food and Drugs (the Commissioner) or
designee in discharging responsibilities as they relate to the
regulation of cellular and gene therapy products.
This committee has 13 voting members. Members are asked to provide
their expert scientific and technical advice to FDA to help make sound
decisions on the safety, effectiveness, appropriate use, and labeling
of cellular and gene therapy products.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the Cellular, Tissue, and Gene Therapies Advisory
Committee. The interested organizations are not bound by the list of
nominees in selecting a candidate. However, if no individual is
selected within 60 days, the Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee of interest should be sent to the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within the 30 days (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process).
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups. Specifically, in this document, nominations for nonvoting
representatives of industry interests are encouraged from the cellular
and gene therapy products biotech industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: June 29, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16828 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P
